BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3092198 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02747
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS. THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED KNOT WOULD NOT ADVANCE TO THE ARTERIAL SURFACE WAS NOT CONFIRMED. ANALYSIS REVEALED A CUFF MISS OCCURRED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFULLY USING TWO PROGLIDE DEVICE IN THE LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMY WAS 6F. DURING THE AAA PROCEDURE THE SHEATH WAS UPSIZED TO 12F AND THE AAA PROCEDURE WAS COMPLETED. REPORTEDLY, AFTER THE AAA PROCEDURE DURING THE ARTERIOTOMY CLOSURE THE KNOT OF THE FIRST PRE-PLACED PROGLIDE SUTURE WAS ADVANCED TO THE ARTERIAL SURFACE. DURING ADVANCING THE KNOT OF THE SECOND PRE-PLACED PROGLIDE, THE KNOT WOULD NOT ADVANCE ALL THE WAY DOWN TO THE ARTERIAL SURFACE. A THIRD PROGLIDE DEVICE WAS DEPLOYED IN THE 12F ARTERIOTOMY AND THE KNOT ALSO WOULD NOT ADVANCE ALL THE WAY DOWN TO THE ARTERIAL SURFACE. A SURGICAL CUT DOWN WAS PERFORMED TO REMOVE ALL THE DEPLOYED SUTURES AND TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A LESS THAN 30 MINUTE DELAY IN THE PROCEDURE DUE TO THE SURGICAL CUT DOWN. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193769 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30218K1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SHEATH: 6F, 12F HEPARIN